Health TrialsbyHealthPanel

Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)

ConditionRelapsed / Refractory Osteosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorLantheus Medical Imaging

About this trial

This is a multi-center, non-randomized, open-label, dosimetry and dose-escalation, cohort-expansion study of LNTH-2403 administered to subjects with relapsed / refractory (R/R) osteosarcoma. This study consists of 2 phases: (1) a dosimetry and dose escalation phase; and (2) a cohort expansion phase.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathologic documented diagnosis of R/R osteosarcoma

Must have disease characterized by at least one of the following (Participants meeting only (b.), only (c.), or only (b. and c.) must be discussed with and receive written approval from the Sponsor to qualify).

Measurable as defined in RECIST 1.1

Evaluable non-measurable disease as per RECIST 1.1

Disqualifiers

Known allergies, hypersensitivity, or intolerance to LNTH-2403 and/or its excipients

Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the participant's safety, compliance with the study, or otherwise impair the assessment of study results

Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy

Known active infection

Trial design

Design model

Single group

Treatments tested in this trial

  • LNTH2403 Phase 1 dose

    Drug

    LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data.

  • Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).

    Drug

    Once the RP2D is selected, phase 2 will commence

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Phase 1- Escalating doses of LNTH-2403 administered once every 8 weeksExperimental treatment 1 intervention
Group B: Phase 2 will evaluate LNTH-2403 as a single agent at the recommended phase 2 doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To identify the maximum tolerated dose (MTD) of LNTH-2403 in participants with R/R osteosarcoma (Ph1)

Incidence of DLTs during the first 8 weeks (DLT evaluation window) after the first dose of LNTH-2403

Time frame
From enrollment to the end of treatment at 8 weeks
2

To evaluate the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph1)

Type, frequency, severity, timing, and relationship to LNTH-2403 of all Treatment-emergent adverse event, (TEAEs) and Serious adverse events, (SAEs)

Time frame
From enrollment to the end of treatment at 8 weeks
3

To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph2)

Event-Free Survival (EFS) at 4 months

Time frame
From enrollment to Event-Free Survival (EFS) at 4 months

Secondary outcomes

1

To assess the preliminary anti-neoplastic activity of LNTH-2403 in participants with R/R osteosarcoma (Ph1)

Event-Free Survival (EFS) at 8 weeks

Time frame
8 weeks
2

To describe the safety and tolerability profile of LNTH-2403 in participants with R/R osteosarcoma (Ph2)

Type, frequency, severity, timing, and relationship to LNTH-2403 of any TEAEs and SAEs

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lantheus Medical Imaging

Lead sponsor

Source ClinicalTrials.gov
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